Echoheart Transvaginal Doppler Probe
FDA 510(k) K060410 · Summit Doppler Systems, Inc.
510(k) numberK060410
Submission
- Device name
- Echoheart Transvaginal Doppler Probe
- Applicant
- Summit Doppler Systems, Inc.
Golden, CO, US - Received
- February 16, 2006
- Decision date
- April 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEK – Monitor, Heart Sound, Fetal, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142769 | Fetal DopplerHEK · Traditional | Icare Newlife Technologies, Inc. | 03/20/2015SE |
| K902190 | Fetal Pulse Detector Model DOP-1HEK · Traditional | Advanced Medical Systems, Inc. | 10/22/1990SE |
| K883334 | Biodop(Tm)HEK · Traditional | Diagnosis Related Systems, Inc. | 12/15/1988SE |
| K771211 | Doppler (UTD-5 & UTD-6)HEK · Traditional | Terumo America, Inc. | 07/14/1977SE |
More from Terumo America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K103693 | Vantage AbiDXN · Traditional | 02/15/2011SE |
| K101816 | STN ProbeITX · Special | 08/19/2010SE |
| K093393 | Lifedop Model 300ABIJAF · Traditional | 12/24/2009SE |
| K090499 | Lifedop Model, L350RMAA · Traditional | 03/31/2009SE |
| K063600 | Vista AvsJAF · Traditional | 12/19/2006SE |
| K024197 | Lifedop DopplerKNG · Traditional | 01/03/2003SE |
Questions and answers
When was Echoheart Transvaginal Doppler Probe cleared by the FDA?
Echoheart Transvaginal Doppler Probe (K060410) received a 510(k) decision of Substantially Equivalent on April 10, 2006, 53 days after the submission was received.
What is the product code of K060410?
The FDA product code is HEK – Monitor, Heart Sound, Fetal, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.